Class 2 Device Recall B. Braun SAFSITE Injection Sites and IV Sets

• Date Initiated by Firm: January 08, 2014
• Date Posted: February 18, 2014
• Recall Status: Terminated on November 03, 2014
• Recall Number: Z-0987-2014
• Recall Event ID: 67236
• 510(K)Number: K954123 K760383 K955585 K060231 K942988
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.; ; A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
• Code Information: Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s 0061343285, exp. 10/31/2018; calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018; catalog #474563, batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018; catalog #490028, batch # 0061324733, exp. 8/31/2018; catalog #490213, batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015; catalog # SS3140, batch # 0061339123, exp. 9/30/2015; catalog #7B0110, batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405, 61327038, 61330199, 61331458, all NonSterile, No Expiration Date; catalog # 7B3179, batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date; catalog #7B3240, batch #s 61324238, exp. 8/31/2018; 61329535, exp. 9/30/2018; 61336490, exp. 7/31/2018; catalog # S5401118N, batch #0061335969, Bulk Non-Sterile, No Expiration Date; and catalog #S5401150N, batch #61326267, NonSterile; No Expiration Date.
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Customer Support; 610-596-2870
• Manufacturer Reason for Recall: Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is intended to provide needle free access on IV and Extension Sets.
• FDA Determined Cause: Process control
• Action: A recall notification letter, dated January 7, 2014, was sent to Users and distributors.
• Quantity in Commerce: 2,357,944
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN INSTRUMENTS; 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN MEDICAL, INC.; 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN OF AMERICA, INC.; 510(K)s with Product Code = FPA and Original Applicant = ELCAM MEDICAL A.C.A.L.